MDR/Vigilance Specialist
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life A typical day involves processing of complaints through intake of source documents, promote them to complaints, follow-up with Reps, determine Reportability, file Regulatory Reports and write Investigation Summaries based on technical product analysis information provided by the plant.
Responsibilities may include the following and other duties may be assigned: Evaluates incoming complaint information and maintains the record in the electronic database. Perform follow-up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data on all complaints.
Determines Reportability of complaints and submits Regulatory Reports to Government Agencies. Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. Writes investigation summaries based on technical product analysis information provided; Ensure record documentation is maintained in a constant state of audit readiness per internal policies.
Liaison with groups who perform additional investigation and who prepare written record of investigation. Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing. Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
Reviews and interprets risk management documentation as it applies to the complaint event. Interacts with multiple departments within Medtronic - RTG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering. Interacts with groups external to Medtronic - such as customers, vendors, health care professional Required knowledge and experience: Bachelor’s degree; Engineering or Science degrees preferred (e.g.
ECE, Biomedical Engineering, ME) 4-8 years of quality assurance or regulatory experience in medical or pharmaceutical industry. Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Strong typing skills and ability to write business documents with minimal supervision.
Strong verbal and written communication skills and ability to work in a team-oriented environment Ability to multitask. Ability to understand the functionality / intended use of complex medical devices. Minimum travel may be required
Nice To Have
- Knowledge of medical devices, their development and quality control.
- Knowledge of medical device standards.
- Knowledge of FDA, MEDDEV, Canadian Regulations.
- Technical Writing experience.
- Good interpersonal skills.
- Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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- This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).